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Government-Owned Inventions; Availability for Licensing

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AGENCY:

National Institutes of Health, Public Health Service, DHHS.

ACTION:

Notice.

SUMMARY:

The invention listed below is owned by an agency of the U.S. Government and is available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

ADDRESSES:

Licensing information and copies of the U.S. patent application listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent application.

Cytotoxic Indeno- and Isoindenoisoquinoline Compounds

Yves G. Pommier (NCI).

U.S. Provisional Patent Application No. 60/469,718 filed 12 May 2003 (DHHS Reference No. E-253-2003/0-US-01).

Licensing Contact: George Pipia; 301/435-5560; pipiag@mail.nih.gov.

The present invention is directed to novel indeno- and isoindenoisoquinoline compounds, their derivatives and their pharmaceutical formulations having anticancer activity, as well as methods of treating cancer. The invention is also directed to methods of preparing these novel compounds. These compounds have been tested against 55 tumor cell lines and have been found to have a strong activity against a wide variety of tumor cell lines, including lung, colon, central nervous system, melanoma, ovarian, renal, prostate and breast cancers, compared with 2-methoxy estradiols. Some of these compounds target topoisomerase I and remain active in camptothecin-resistant cancer cells. It is expected that these compounds will be very useful in the treatment of a wide variety of cancers.

Identification of Novel Birt-Hogg-Dubé (BHD) Gene

Laura S. Schmidt (NCI).

PCT Application No. PCT/US03/17227 filed 30 May 2003 (DHHS Reference No. E-190-2002/2-PCT-01).

Licensing Contact: George Pipia; 301/435-5560; pipiag@mail.nih.gov.

Birt-Hogg-Dubé (BHD) syndrome is an inherited autosomal dominant neoplasia syndrome characterized by benign hair follicle tumors and is associated with a higher risk for developing renal cancer, spontaneous pneumothorax and/or lung cysts.

The present invention describes identification of the BHD syndrome associated germline mutations in a novel human gene, herein called BHD gene. This gene encodes for the protein, folliculin, functions of which remain currently unknown.

This discovery makes possible the development of a diagnostic method for BHD syndrome using a simple blood test. The test is particularly useful in detecting BHD mutations in asymptomatic carriers within BHD families.

Patients with kidney tumors can be evaluated for BHD gene mutations using a similar genetic diagnostic test, which will allow for a more accurate diagnosis of a kidney cancer and improved patient prognosis. The BHD encoding sequence is the third gene found to be responsible for inherited kidney cancer, and mutation testing allows for a correct diagnosis and initiation of the proper treatment, which is different for each of the types of kidney cancer caused by the three genes.

Methods of using BHD encoding sequence also allows for a differential genetic diagnosis of spontaneous pneumothorax, or collapsed lung. Since collapsed lung can be caused by several factors, a BHD diagnostic test allows a physician to determine predisposition to and possible recurrence of additional spontaneous pneumothoraces due to mutation(s) in the BHD gene.Start Printed Page 63114

The discovery should also lead to the development of novel pharmaceutical products and methods for treating BHD skin lesions using creams containing the BHD gene product, folliculin. Such products and methods of treatment are expected to reduce the size and appearance of the benign hair follicle tumors.

The disclosed technology will provide new and exciting methodologies to correctly diagnose BHD syndrome and should lead to the development of novel pharmaceutical reagents for treatment of BHD skin lesions as well as other skin diseases.

This research is also described in: Nickerson et al., Cancer Cell 2: 157, 2002; Zbar et al., Cancer Epidem. Bio. Prev. 11: 393, 2002; Schmidt et al., Am. J. Hum. Genet. 69: 876, 2001; Toro et al., Arch. Dermatol. 135: 1195, 1999.

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Dated: October 27, 2003.

Steven M. Ferguson,

Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health.

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[FR Doc. 03-28056 Filed 11-6-03; 8:45 am]

BILLING CODE 4140-01-P